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This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage).
Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.
Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications.
However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance.
Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not.
There is not enough evidence in pediatric patients that this affirmation is also true.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical Bowel Preparation | Active Comparator | Patients will receive enteric polyethylene glycol at 100 ml/kg/dose during 4 hours, and up to 3 times, prior to surgery. Enemas with normal saline 20 ml/kg/do will be administered through the stomas 3 times a day |
|
| No Mechanical Bowel Preparation | Experimental | Patients will not receive any preparation prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Mechanical Bowel Preparation | Drug | no enemas or oral laxatives will be given in this group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Related Complications | Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilio J Fernandez Portilla, MD | Contact | 52289917 | 2208 | drejfernandez@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infantil de Mexico Federico Gomez | Recruiting | Mexico City | 06720 | Mexico |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 18, 2021 | |
| Reset | Mar 11, 2021 |
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| Mechanical Bowel Preparation | Drug | oral laxatives (polyethylenglycol at 100 ml/kg/dose for up to 3 times) and stoma enemas (20mlkgdo of normal saline 3 times a day) will be prescribed |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 18, 2021 | Mar 11, 2021 |